Vor Bio’s Telitacicept Gains Sjögren’s Approval, Delivers 59% IgAN Proteinuria Drop
VOR•China’s NMPA fully approved telitacicept as the first therapy for adult Sjögren’s disease, based on Phase 3 data demonstrating significant ESSDAI and ESSPRI improvements. The agency also granted conditional approval for IgA nephropathy after TELIGAN Phase 3 showed a 59% reduction in urinary protein-to-creatinine ratio at Week 39.
1. NMPA Grants Full Approval for Sjögren’s Disease
The NMPA approved telitacicept for treating adult Sjögren’s disease, marking the first and only therapy for this indication in China. Approval was based on a Phase 3 trial demonstrating statistically significant and clinically meaningful reductions in disease activity index (ESSDAI) and patient-reported symptoms (ESSPRI) sustained through Week 48, representing the fifth approved indication for the drug.
2. Conditional Approval for IgA Nephropathy with 59% UPCR Reduction
Telitacicept received conditional approval for adult IgA nephropathy following positive Phase 2 and Phase 3 TELIGAN results showing a 59% decline in urinary protein-to-creatinine ratio at Week 39 and stable eGFR compared with placebo. This marks the fourth indication approval, underpinned by favorable safety data and immunological effects consistent with dual BAFF/APRIL inhibition.
3. Commercial Rights and Global Development Outlook
RemeGen holds development and commercialization rights in Greater China while Vor Bio retains exclusive ex-China rights and is positioned to earn royalties on Chinese sales. Vor Bio is advancing global Phase 3 trials in Sjögren’s disease and generalized myasthenia gravis in the US, Europe and Japan, targeting additional regulatory approvals and revenue milestones.
